Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Extrinsic Atopic Dermatitis
1 other identifier
interventional
30
1 country
10
Brief Summary
The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body reacts to the drug) compared to placebo (an inert substance) in patients with moderate-to-severe extrinsic Atopic Dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2010
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 10, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedOctober 4, 2012
October 1, 2012
1.6 years
December 10, 2010
October 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12.
12 weeks
Secondary Outcomes (1)
The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.
12 weeks
Study Arms (3)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit
- Investigator's Global Assessment (IGA) score of \>/= 3 at the screening and baseline visits
- \>/= 15% body surface area (BSA) of AD involvement at the screening and baseline visits
- History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit
- Willing and able to comply with clinic visits and study-related procedures
- Patient able to read and understand, and willing to sign the informed consent form
You may not qualify if:
- A positive QuantiFERON® - TB (tuberculosis) Gold Test at the screening visit
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV)
- Treatment with an investigational drug within 8 weeks before the baseline visit
- Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
- Treatment with systemic corticosteroids within 4 weeks before the baseline visit
- Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
- Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
- Chronic or acute infection requiring treatment
- History of clinical parasite infection, other than treated trichomoniasis
- History of malignancy within 5 years before the baseline visit
- Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
- Pregnant or breast-feeding women
- Unwilling to use adequate birth control, if of reproductive potential and sexually active
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (10)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Related Publications (2)
Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.
PMID: 25482871DERIVEDBeck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
PMID: 25006719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2010
First Posted
December 14, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-10